Efficacy and Safety of Dapagliflozin in Combination With Glimepiride (a Sulphonylurea) in Type 2 Diabetes Patients
NCT ID: NCT00680745
Last Updated: 2013-10-14
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
597 participants
INTERVENTIONAL
2008-04-30
2010-05-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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1
dapagliflozin 2.5mg + Glimepiride
dapagliflozin
tablet oral 2.5, 5, or 10 mg total daily dose once daily 48 weeks
Glimepiride
tablet oral 2.5, 5, or 10 mg total daily dose once daily 48 weeks
metformin hydrochloride
rescue medication oral dosing in accordance with the manufacturer's recommendations and clinical practice
pioglitazone hydrochloride
rescue medication oral dosing in accordance with the manufacturer's recommendations and clinical practice
Rosiglitazone
rescue medication oral dosing in accordance with the manufacturer's recommendations and clinical practice
2
dapagliflozin 5mg + Glimepiride
dapagliflozin
tablet oral 2.5, 5, or 10 mg total daily dose once daily 48 weeks
Glimepiride
tablet oral 2.5, 5, or 10 mg total daily dose once daily 48 weeks
metformin hydrochloride
rescue medication oral dosing in accordance with the manufacturer's recommendations and clinical practice
pioglitazone hydrochloride
rescue medication oral dosing in accordance with the manufacturer's recommendations and clinical practice
Rosiglitazone
rescue medication oral dosing in accordance with the manufacturer's recommendations and clinical practice
3
dapagliflozin 10mg + Glimepiride
dapagliflozin
tablet oral 2.5, 5, or 10 mg total daily dose once daily 48 weeks
Glimepiride
tablet oral 2.5, 5, or 10 mg total daily dose once daily 48 weeks
metformin hydrochloride
rescue medication oral dosing in accordance with the manufacturer's recommendations and clinical practice
pioglitazone hydrochloride
rescue medication oral dosing in accordance with the manufacturer's recommendations and clinical practice
Rosiglitazone
rescue medication oral dosing in accordance with the manufacturer's recommendations and clinical practice
4
Placebo + Glimepiride
Glimepiride
tablet oral 2.5, 5, or 10 mg total daily dose once daily 48 weeks
metformin hydrochloride
rescue medication oral dosing in accordance with the manufacturer's recommendations and clinical practice
pioglitazone hydrochloride
rescue medication oral dosing in accordance with the manufacturer's recommendations and clinical practice
Rosiglitazone
rescue medication oral dosing in accordance with the manufacturer's recommendations and clinical practice
Interventions
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dapagliflozin
tablet oral 2.5, 5, or 10 mg total daily dose once daily 48 weeks
Glimepiride
tablet oral 2.5, 5, or 10 mg total daily dose once daily 48 weeks
metformin hydrochloride
rescue medication oral dosing in accordance with the manufacturer's recommendations and clinical practice
pioglitazone hydrochloride
rescue medication oral dosing in accordance with the manufacturer's recommendations and clinical practice
Rosiglitazone
rescue medication oral dosing in accordance with the manufacturer's recommendations and clinical practice
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Treatment with a stable sulphonylurea monotherapy dose that is at least half the maximal recommended dose for a minimum of 8 weeks prior to study
* Inadequate glycaemic control, defined as A1C ≥ 7.0 % and ≤ 10%
Exclusion Criteria
* Hepatic (liver) impairment
* Renal (kidney) failure or dysfunction
18 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
AstraZeneca
INDUSTRY
Responsible Party
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Principal Investigators
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Krzysztof Strojek, Prof. Dr.
Role: PRINCIPAL_INVESTIGATOR
Silesian Medical University3-Maja 13/15, 41-800 Zabrze; Poland
Locations
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Research Site
Blansko, , Czechia
Research Site
Bruntál, , Czechia
Research Site
Břeclav, , Czechia
Research Site
Hodonín, , Czechia
Research Site
Ostrava - Belsky Les, , Czechia
Research Site
Pilsen, , Czechia
Research Site
Prague, , Czechia
Research Site
Pribram VIII, , Czechia
Research Site
Rakovník, , Czechia
Research Site
Semily, , Czechia
Research Site
Balatonfüred, , Hungary
Research Site
Békéscsaba, , Hungary
Research Site
Budapest, , Hungary
Research Site
Csongrád, , Hungary
Research Site
Eger, , Hungary
Research Site
Gyöngyös, , Hungary
Research Site
Kecskemét, , Hungary
Research Site
Makó, , Hungary
Research Site
Miskolc, , Hungary
Research Site
Mosonmagyaróvár, , Hungary
Research Site
Siófok, , Hungary
Research Site
Szentes, , Hungary
Research Site
Tát, , Hungary
Research Site
Zalaegerszeg, , Hungary
Research Site
Cebu City, , Philippines
Research Site
Manila, , Philippines
Research Site
Marikina City, , Philippines
Research Site
Pasig, , Philippines
Research Site
Bielsko-Biala, , Poland
Research Site
Bydgoszcz, , Poland
Research Site
Chojnice, , Poland
Research Site
Chrzanów, , Poland
Research Site
Ciechocinek, , Poland
Research Site
Czechowice-Dziedzice, , Poland
Research Site
Elblag, , Poland
Research Site
Gdansk, , Poland
Research Site
Gniewkowo, , Poland
Research Site
Grudziądz, , Poland
Research Site
Iława, , Poland
Research Site
Krakow, , Poland
Research Site
Mrągowo, , Poland
Research Site
Poznan, , Poland
Research Site
Płock, , Poland
Research Site
Ruda Śląska, , Poland
Research Site
Sopot, , Poland
Research Site
Torun, , Poland
Research Site
Wroclaw, , Poland
Research Site
Zabrze, , Poland
Research Site
Zielona Góra, , Poland
Research Site
Żory, , Poland
Research Site
Wŏnju, Gangwon-do, South Korea
Research Site
Suwon, Gyeonggi-do, South Korea
Research Site
Jeonju, Jeollabuk-do, South Korea
Research Site
Bucheon-si, , South Korea
Research Site
Incheon, , South Korea
Research Site
Seongnam, , South Korea
Research Site
Seoul, , South Korea
Research Site
Uljeongbu, , South Korea
Research Site
Bangkok, , Thailand
Research Site
Chiang Mai, , Thailand
Research Site
Dnipropetrov'sk, , Ukraine
Research Site
Donetsk, , Ukraine
Research Site
Kharkiv, , Ukraine
Research Site
Kiev, , Ukraine
Research Site
Vinnytsia, , Ukraine
Research Site
Zaporizhzhya, , Ukraine
Countries
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References
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Shah M, Stolbov L, Yakovleva T, Tang W, Sokolov V, Penland RC, Boulton D, Parkinson J. A model-based approach to investigating the relationship between glucose-insulin dynamics and dapagliflozin treatment effect in patients with type 2 diabetes. Diabetes Obes Metab. 2021 Apr;23(4):991-1000. doi: 10.1111/dom.14305. Epub 2021 Jan 25.
Strojek K, Yoon KH, Hruba V, Elze M, Langkilde AM, Parikh S. [Effect of dapagliflozin in patients with type 2 diabetes who have inadequate glycaemic control with glimepiride]. Dtsch Med Wochenschr. 2013 Apr;138 Suppl 1:S16-26. doi: 10.1055/s-0032-1305277. Epub 2013 Mar 25. German.
Strojek K, Yoon KH, Hruba V, Elze M, Langkilde AM, Parikh S. Effect of dapagliflozin in patients with type 2 diabetes who have inadequate glycaemic control with glimepiride: a randomized, 24-week, double-blind, placebo-controlled trial. Diabetes Obes Metab. 2011 Oct;13(10):928-38. doi: 10.1111/j.1463-1326.2011.01434.x.
Other Identifiers
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D1690C00005
Identifier Type: -
Identifier Source: org_study_id